Doheny Eye Institute, University of California, Los Angeles.
The Emmes Corporation, Rockville, Maryland.
JAMA Ophthalmol. 2019 Mar 1;137(3):281-287. doi: 10.1001/jamaophthalmol.2018.6111.
Information is needed to assess switching treatment in eyes with a poor response to 6 months of monthly administration of aflibercept or bevacizumab for macular edema from central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
To investigate visual acuity letter score (VALS) and central subfield thickness (CST) changes from month 6 to 12 among eyes with a poor response at month 6 to monthly dosing of aflibercept or bevacizumab in the Study of Comparative Treatments for Retinal Vein Occlusion 2.
DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) was conducted at 66 private practice or academic centers in the United States. Participants included 49 patients (1 eye from each patient evaluated) with CRVO- or HRVO-associated macular edema and a protocol-defined poor response to aflibercept or bevacizumab treatment at month 6. The first month 6 visit occurred on September 8, 2015, and the last month 12 visit occurred on October 24, 2016.
Treatment in eyes receiving monthly aflibercept was switched to a dexamethasone implant at month 6 and, if needed, at months 9, 10, or 11. Treatment in eyes receiving monthly bevacizumab was switched to aflibercept at months 6, 7, and 8, and then to a treat-and-extend aflibercept regimen until month 12.
Change from month 6 to 12 in VALS and CST.
Of the 49 participants at month 6, aflibercept treatment had failed in 14 (6 [43%] women; mean [SD] age, 70.4 [13.0] years). Bevacizumab treatment had failed in 35 patients (16 [46%] women; mean age, 70.0 [13.2] years). In 14 eyes with treatment switched from aflibercept to dexamethasone, the estimated mean change from month 6 to 12 in VALS was 2.63 (95% CI, -3.29 to 8.56; P = .37) and 46.0 μm (95% CI, -80.9 to 172.9 μm; P = .46) for CST. In 35 eyes with treatment switched from bevacizumab to aflibercept, the estimated mean change from month 6 to 12 in VALS was 10.27 (95% CI, 6.05-14.49; P < .001) and -125.4 μm (95% CI, -180.9 to -69.9 μm; P < .001) for CST.
Eyes treated with aflibercept after a poor response to bevacizumab had improvement in VALS and CST. Few eyes had a poor response to aflibercept, and therefore, few eyes were switched to dexamethasone. Caution is warranted in interpreting these results owing to the small number of eyes and lack of comparison groups. These factors preclude definitive assessment of whether the switching strategy is superior to maintaining treatment.
重要性:需要评估在因中央视网膜静脉阻塞(CRVO)或半视网膜静脉阻塞(HRVO)而导致的黄斑水肿,使用阿柏西普或贝伐单抗每月治疗 6 个月后反应不佳的情况下,转换治疗的信息。
目的:评估 Study of Comparative Treatments for Retinal Vein Occlusion 2(SCORE2)中在第 6 个月对每月给予阿柏西普或贝伐单抗治疗反应不佳的患者,从第 6 个月到第 12 个月的视力字母评分(VALS)和中央子场厚度(CST)变化。
设计、设置和参与者:这是在美国 66 个私人诊所或学术中心进行的 SCORE2 的二次分析。参与者包括 49 名患者(每名患者评估 1 只眼),他们患有 CRVO 或 HRVO 相关的黄斑水肿,并且在第 6 个月时对阿柏西普或贝伐单抗治疗有明确的不良反应。第一次第 6 个月就诊于 2015 年 9 月 8 日,最后一次第 12 个月就诊于 2016 年 10 月 24 日。
干预措施:在接受每月阿柏西普治疗的眼睛中,在第 6 个月时转换为地塞米松植入物,如果需要,在第 9、10 或 11 个月时转换。在接受每月贝伐单抗治疗的眼睛中,在第 6、7 和 8 个月时转换为阿柏西普,然后转为阿柏西普延长治疗方案,直到第 12 个月。
主要结果和测量:从第 6 个月到第 12 个月的 VALS 和 CST 变化。
结果:在第 6 个月的 49 名参与者中,阿柏西普治疗失败了 14 例(6 例为女性;平均[标准差]年龄为 70.4[13.0]岁)。贝伐单抗治疗失败了 35 例患者(16 例为女性;平均年龄为 70.0[13.2]岁)。在 14 只从阿柏西普转换为地塞米松的眼睛中,从第 6 个月到第 12 个月,VALS 的估计平均变化为 2.63(95%CI,-3.29 至 8.56;P = .37)和 CST 的 46.0μm(95%CI,-80.9 至 172.9μm;P = .46)。在 35 只从贝伐单抗转换为阿柏西普的眼睛中,从第 6 个月到第 12 个月,VALS 的估计平均变化为 10.27(95%CI,6.05-14.49;P < .001)和 CST 的-125.4μm(95%CI,-180.9 至-69.9μm;P < .001)。
结论和相关性:在对贝伐单抗治疗反应不佳的患者中使用阿柏西普治疗后,VALS 和 CST 有所改善。对阿柏西普治疗反应不佳的眼睛很少,因此,很少有眼睛转换为地塞米松。由于眼睛数量少且缺乏对照组,因此在解释这些结果时应谨慎。这些因素排除了对转换策略是否优于维持治疗的明确评估。